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Wednesday, February 15, 2012

During a fireside chat at the BIOCEO meeting in New York this week, Pfizer’s president of worldwide R&D Mikael Dolsten ranged over the company’s R&D spend (down!), FDA filings (up!), and externalization initiatives (off the scale). He also offered his view on the more transformative products in Pfizer’s late-stage lineup: bullish on tofacitinib and Prevnar 13, inscrutable on bapineuzumab.

But his comments on Pfizer’s budding oncology franchise caught this blogger’s ear. Dolsten rightly highlighted Pfizer oncology’s strengths in tyrosine kinase biology, mentioning the recent launches of Xalkori for advanced NSCLC and Inlyta for advanced renal cell carcinoma, and also bragged about Pfizer’s emergence as a “significant player” in antibody conjugates.

When I pointed out that Xalkori, although a stunning development story, was in all likelihood a modest commercial story, the R&D head took exception. He noted its remaining commercial potential in inhibiting the ALK translocation, with several additional indications currently in Phase I, and Pfizer’s ongoing exploration of Xalkori’s other targets, including c-MET and the recently disclosed ROS1. But after years of false starts and frenetic deal-making, would all this and more be enough to help Pfizer turn the corner with its oncology business?

Xalkori -- approved in just under five months from submission, and only four years from target identification -- represented the first time that a targeted cancer therapeutic was approved by FDA based on Phase I data. The crizotinib team in La Jolla had spent about 6 years investigating the molecule’s activity against gastric tumors by inhibiting its c-MET target. A chance publication in Nature describing the role of the ALK fusion gene in NSCLC made them rethink the target and the population, put the compound on a new clinical path, and the rest is history.

If Xalkori is a window into drug development innovation (read our In Vivo feature on that subject, published in the next issue of the magazine), it remains to be seen whether the process can be templated and repeated in project after project. Pfizer’s restructuring into fiscally responsible, therapeutically aligned business units 4 years ago played an important role in the Xalkori development story. Restructurings are disruptive, but controllable. Likewise the size of Pfizer’s therapeutic footprint and the right-sizing of its portfolio for optimum risk and return. But the chance publication in Nature at around the time the c-MET theory was running out of gas – uncontrollable. And the tight, totally idiosyncratic interaction between La Jolla’s translational group and the clinical research group – basically, the chemistry between scientists – very hard to control.

Dolsten said in an exclusive interview following the BIOCEO chat that the move into BUs incentivized scientists “by pulling them into the business dimension of R&D” -- e.g., resource tradeoffs, financial responsibility, speed-to-market pressures – “in addition to the science.” He also warmed to idea of the human element in drug R&D: “These factors are often ignored. For instance, having the right talent. Passion in scientists -- this is not a 9-5 job, they're here because they feel part of a mission to understand oncogene science as it emerges. And part of is, yes, you need to be adaptive to change. We try to build that into our culture, an ownership culture, in which, as new science breaks, we embrace the opportunity to rapidly adapt to new knowledge.”

Dolsten’s implication was that the human element – the passion, adaptability, and close interaction – can be controlled. Maybe. Note that he didn’t go near the chance element – a fortuitous publication, a serendipitous lab finding. But let’s see if Pfizer oncology can repeat the speed and sure-footedness of Xalkori’s approval. Not just getting the next round of candidates approved and launched, but assuring their performance in the market, their reception by payers, and their expansion into other indications and settings. That’ll make a believer out of me. -- Michael Goodman

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